Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-10-31

Brief Summary

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The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

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Detailed Description

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The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sildenafil ≥20mg three times daily

Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH

sildenafil citrate

Intervention Type DRUG

Sildenafil citrate, 20mg oral tablets, taken at least three times daily

Interventions

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sildenafil citrate

Sildenafil citrate, 20mg oral tablets, taken at least three times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must be at least 18 years of age at study index;
* Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of \> 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
* Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation

Exclusion Criteria

* Patient has known contraindications to sildenafil at study index;
* Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No